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QA Compliance Official-Swiftwater, PA

Swiftwater, Pennsylvania

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Overview

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our Sanofi Pasteur Swiftwater, PA site, where we both research and manufacture vaccines since 1897, has had a tremendous impact on global health and the quality of human life. Nestled among the Pocono Mountains in Swiftwater, Pennsylvania, Sanofi Pasteur is home to state-of-the-industry facilities—and a rich and unique history. Our Swiftwater campus is more than 500 acres, housing 44 buildings and encompassing more than one million square feet of building space. Many of our facilities, while bright and modern, still retain the rustic charm of the original stonework.

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Benefits

  • Health & Wellness

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • Financial

    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

  • Culture

    At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.

  • Work/Life Balance

    Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.

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Quote

"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."

C. Richard Cioci Clinical Science Associate – Pompe Ontario East & Atlantic

"I am continually impressed at the dedication that Sanofi has to the patients for whom we provide solutions."

Suncére Hernandez Area Business Manager, Multiple Sclerosis

"I give thanks to my powerhouse team for reminding me that I have a support system behind me, pushing me forward."

Bob Shustack Head of Global Support Functions Finance, North America

Responsibilities

The Manager Quality Compliance will ensure compliance with cGMP, regulatory and internal requirements regarding the manufacturing, testing and distributing of products through formal QA Audits, investigations, training and recommendations to procedures. 

Evaluate and provide QA recommendations on all products, systems and issues that are/may be affected by regulatory or cGMP requirements.

Position Responsibilities:

  • Participate in project teams involved with the facilities, processes and equipment for the manufacturing of vaccines
  • Ensure a constant state of inspection readiness and  all audit observations are addressed
  • Support FDA and international regulatory bodies during site inspections
  • Provide input and guidance to the team conducting incident investigations
  • Make recommendations to department management regarding results of investigations and process improvements
  • Manage our quality systems to ensure that corrective and preventative actions are completed
  • Provide support to functional areas regarding the Change Control System

Basic Qualifications:

  • A Bachelor’s Degree is required
  • 5-10 years’ experience in a cGMP production facility
  • 1-3 years' experience working with Quality systems

Technical Competencies:

  • Quality Assurance experience in a Pharma/Vaccine production facility
  • Working knowledge of cGMPs and regulatory requirements
  • Knowledge of vaccines/biologics products and associated technologies
  • Previous experience with upstream processing of Drug Substance and/or Quality Control testing  in a cGMP facility
  • The ability to work on cross functional project teams
  • Meet/Exceed project timelines/deliverables
  • Experience with Quality Systems including: SAP, Quality eDoc, LabWare, TrackWise and MS Office
  • Strength in several LEAD Competencies - Think Strategically, Lead Teams, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SP     

#LI-SP

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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